Regulatory Filings • Jan 26, 2016
Regulatory Filings
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Malakoff, January 26, 2016 – Theraclion (Alternext, FR0010120402 – ALTHE), a company specialized in leading edge medical equipment for echotherapy, announced today the submission of a « Forfait Innovation » dossier to the French Ministry of Health.
On January 23, 2016, as part of National Health Innovation Day in France, Ms. Marisol Touraine, the French Health Minister, announced that review of Theraclion's submission was underway. Theraclion is the first company to submit an application for « Forfait Innovation » funding under the definitive rules put in place on February 16, 2015.
« Forfait Innovation » is a new reimbursement mechanism for innovative medical devices designed to accelerate market adoption of novel technologies. A clinical trial or a cost effectiveness study is conducted to generate the missing data necessary to compare the innovative approach with the standard of care. Since the introduction of « Forfait Innovation » in 2009, two pilot projects have been launched. The 2015 reform clarified the process required to ultimately receive coverage.
« Theraclion is proud to be working hand in hand with the Ministry of Health to demonstrate that the Forfait Innovation is a powerful tool capable of both supporting medical innovation and ensuring the vitality of French scientific development and industrialization, » said David Caumartin, CEO of Theraclion.
http://social-sante.gouv.fr/actualites/presse/discours/article/intervention-de-marisol-touraine-a-loccasion-de-inauguration-de-la-premiere
Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound.
Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 30 people, 53 percent of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion's website: www.theraclion.com.
Theraclion is listed on Alternext Paris. PEA-PME eligible Mnemonic: ALTHE - ISIN Code: FR0010120402
Tel.: +33 (0)1 55 48 90 70 Tel.: +33 (0)1 44 71 94 94 [email protected] [email protected]
Press Relations Estelle Reine-Adélaïde / Florence Calba Tel.: + 33 (0)1 44 90 82 54 [email protected]
David Caumartin Financial Communication and Relations Chief Executive Officer Emmanuel Huynh / Valentine Brouchot
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